FDA Lifts Clinical Hold On vTv Therapeutics' Phase 3 Diabetes Trial, Stock Surges
Tv Therapeutics' Phase 3 trial for cadisegliatin in type 1 diabetes resumes after FDA lifts hold, with a revised six-month ...
MPR3h
Finerenone Under Review for Patients With Heart Failure and LVEF ≥40%
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of ...
Business Wire5d
LGM Pharma Invests $6M in U.S. Drug Manufacturing Capabilities for Liquids, Suspensions, Semi-Solids, and Suppositories
The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...
PDS Biotech gets IND application clearance for colorectal cancer treatment
PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...
Ophthalmology Times6d
FDA accepts new drug application for low-dose atropine from Sydnexis
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
PDS Biotech Announces FDA Clearance of IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer
Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...
Access to Compounded GLP-1s Is Drying Up. Here’s What to Know About the Copycat Weight-Loss Drugs.
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
Healio24d
FDA clears investigational new drug application for Zabalafin Hydrogel
Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively. A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the ...
Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
Ivor Elrifi, CEO of Tiziana Life Sciences, expressed enthusiasm about this milestone, stating, "We are excited to initiate this important clinical study with the support of the ALS Association grant.
Healio6d
FDA accepts new drug application for SYD-101 to treat pediatric myopia progression
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...